Documentation of distribution Sample Clauses

Documentation of distribution. Distributor shall maintain distribution records that permit the tracing of the Processed Tissue to the consignee. Distribution records must include: Date of order Consignee name and address Identification of person placing the order Type and quantity of tissue ordered Information regarding tissue shipped Identification numbers of tissue’s Expiration date of tissue Date of shipment Mode of transportation Name of Individual filling order Additional requirements: Distributor must insure that all storage equipment (i.e., refrigerator(s)) is regularly maintained (i.e. preventative maintenance program), calibrated, and monitored. Monitoring of refrigerators may consist of the installation of a continuous temperature recording device or a routine (once each working day) and documented check of temperature utilizing a refrigerator thermometer. Acceptable temperature range for the storage of Processed Tissue is 1 - 10°C. Processed Tissue may be stored in a standard household refrigerator provided that this temperature range can be maintained. All reports of complaints or adverse outcomes must be required to be forwarded immediately to LifeCell. All expired, returned, damaged, or otherwise compromised packages or grafts must be returned to LifeCell. Packages containing Processed Tissue cannot be relabeled. Existing labeling cannot be altered. ▇▇▇▇▇▇ Medical Technology Document No.: PS02-0013 Issued Rev.: 07 Revision Draft Date: July 26, 2007 Issue Date: July 31, 2007 Effective Date: July 31, 2007 Supersedes: PS02-0013, Rev.: 06 Supersedes Date: January 25, 2007 Prepared by: ▇▇▇▇▇ ▇▇▇▇▇▇, Product Development Engineering Approved by: ▇▇▇ ▇▇▇▇▇▇▇, Biologics Development ▇▇▇▇▇▇▇ ▇▇▇▇, Material Engineering ▇▇▇▇▇▇ ▇▇▇▇▇▇, Industrial Engineering ▇▇▇▇ ▇▇▇, Marketing ▇▇▇▇▇ ▇▇▇▇▇, Regulatory Affairs ▇▇▇ ▇▇▇▇▇▇▇, International Marketing ▇▇▇▇ ▇▇▇▇, Production Management ▇▇▇ ▇▇▇▇▇, Process Engineering ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Quality Assurance ▇▇▇▇▇ ▇▇▇▇▇▇▇, Quality Engineering ▇▇▇▇▇ ▇▇▇▇▇▇▇, Purchasing ▇▇▇▇ ▇▇▇▇▇, Clinical ▇▇▇▇▇▇ ▇▇▇▇▇, Sterilization Assurance ▇▇▇▇ ▇▇▇▇▇, Packaging Engineering Dept/Function Approver Signature and Date Documentation ▇▇▇▇ ▇▇▇▇▇▇ /s/ ▇▇▇▇ ▇▇▇▇▇▇ 7-31-2007 Product Specification for GRAFTJACKET® Regenerative Tissue Matrix Issued Document No.: PS02-0013 Rev.: 07